ARX788 in HER2-positive Metastatic Breast Cancer Patients

Evaluate the Efficacy and Safety of ARX788 Given Every 6 Weeks in Patients with HER2-positive Advanced Breast Cancer

A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.

Study Overview

• Status: Not yet recruiting
• Conditions: HER2-positive, Metastatic Breast Cancer
• Intervention / Treatment: Drug: ARX788

Detailed Description

A single arm, phase 2 study of ARX788 in HER2-positive, metastatic breast cancer patients. The ARX788 will be administered every 6 weeks (Q6W) intravenous (IV) infusion.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Min Yan; Phone Number: +86 15713857388; Email: ym200678@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 to 75 years old (including upper and lower limits), male or female;
• Unresectable locally advanced, recurrent or metastatic BC;
• Has previously received ≤ two lines of chemotherapy (excluding hormone therapy) for recurrent or metastatic BC;
• Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
• Has at least one measurable target lesion as per RECIST1.1 criteria;
• Has recovered from any AE (≤ Grade 1) related to prior surgery and prior cancer treatment;
• Adequate bone marrow, liver, kidney and coagulation function;
• ECOG Performance Status Score of 0-1;
• Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.

Exclusion Criteria:

• Has known history to be allergic to any active ingredient or excipient of ARX788;
• With meningeal metastases or disseminated brain metastases or active brain metastases, who need radiation, surgery or drug therapy;
• Has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment;
• Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease;
• Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;
• Has cardiac insufficiency;
• Uncontrolled hypertension;
• Has evidence of severe or uncontrollable systemic diseases;
• Received live vaccines within 4 weeks before the first use of the investigational product or plans to receive live vaccines during the trial;
• Breastfeeding female, or who has childbearing potential with a positive baseline pregnancy test or who is unwilling to use effective contraception during the trial;
• Is unwilling or unable to stop wearing corneal contact lens during the trial;
• Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product;
• Has any mental or cognitive disorder that may restrict his/her understanding and execution of the informed consent form;
• Other conditions that the Investigator considers inappropriate for participation in this trial, such as poor compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARX788	Drug: ARX788; 2.2 mg/kg IV infusion on Day 1 of each 42-day treatment cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective remission rate (ORR)	ORR is defined as the percentage of participants in the analysis population who have CR or PR per RECIST 1.1.	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate (DCR)	DCR is defined as the percentage of participants in the analysis population who have CR or PR or SD per RECIST 1.1.	up to 2 years
Duration of relief (DOR)	DOR is defined as the interval from response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first.	From response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first, assessed up to 2 years.
Progression-free survival (PFS)	PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first.	From first dose to first documented disease progression (PD) or death from any cause, whichever occurred first, assessed up to 2 years.
Overall survival (OS)	OS was defined as the time from the first dose of study drug to any-cause death.	From the date of first dose of study drug to any-cause death, assessed up to 5 years
The number of subjects experiencing adverse event TEAEs	Number of participants with TEAEs as assessed by CTCAE v5.0	up to 2 years
Pharmacokinetic parameter: Maximum concentration (Cmax)		At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Time to Cmax (tmax)		At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Terminal half-life (t1/2)		At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Area under the concentration-time curve from zero extrapolated to infinity [AUC(0-inf)]		At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Area under the concentration-time curve from zero to the last quantifiable concentration [AUC(0-last)]		At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Terminal rate constant (λz)		At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Systemic clearance (CL)		At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Volume of distribution (Vz)		At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Volume of distribution at steady state (Vss)		At the end of Cycle 3 (each cycle is 42 days)
Pharmacokinetic parameter: Trough concentration (Ctrough)		At the end of Cycle 3 (each cycle is 42 days)

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2024
• Primary Completion (Estimated): November 20, 2025
• Study Completion (Estimated): November 20, 2029

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 27, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 27, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: HER2-positive breast cancer; ARX788; Q6W
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ACE-Breast-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No